NCT04794452

Brief Summary

To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

18 days

First QC Date

February 14, 2021

Last Update Submit

March 10, 2021

Conditions

Plaque, Dental

Outcome Measures

Primary Outcomes (1)

  • Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal

    Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.

    up to 2 weeks

Study Arms (2)

Battery operated toothbrush

ACTIVE COMPARATOR

battery operated toothbrush

Device: Battery operated toothbrush

Manual toothbrush

ACTIVE COMPARATOR

Manual toothbrush

Device: Manual toothbrush

Interventions

Battery operated toothbrushDEVICE

Device on plaque removal efficacy

Battery operated toothbrush
Manual toothbrushDEVICE

Device on plaque removal efficacy

Manual toothbrush

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 8 years
  • Be a regular manual toothbrush user.

You may not qualify if:

  • Have any physical limitations or restrictions which might preclude normal tooth brushing.
  • Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
  • Have fixed or removable orthodontic appliances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2 C, Canada

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2021

First Posted

March 12, 2021

Study Start

November 23, 2020

Primary Completion

December 11, 2020

Study Completion

December 11, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)